Surgical system

ABSTRACT

A surgical device is disclosed. The surgical device comprises a housing, a cutting element, a spool, a piston, and a spring. The cutting element extends from the housing at the distal end of the housing. The cutting element comprises an outer cannula and an inner cannula. The spool is engaged with the outer cannula. The piston is engaged with the inner cannula. A spring is positioned between the spool and the piston. The spool is translated distally to translate the outer cannula towards the distal end. And the piston translates the inner cannula towards the distal end to sever tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of U.S. Ser. No. 11/865,092, with afiling date of Oct. 1, 2007, which is related to U.S. Ser. No.11/875,560, with a filing date of Oct. 19, 2007, which applications arehereby incorporated by reference in their entirety.

FIELD

This disclosure relates to biopsy instruments and methods for taking abiopsy. More specifically, this disclosure relates to disposable biopsydevices for removing several tissue samples using a single insertion.

BACKGROUND INFORMATION

In the diagnosis and treatment of breast cancer, it is often necessaryto remove multiple tissue samples from a suspicious mass. The suspiciousmass is typically discovered during a preliminary examination involvingvisual examination, palpitation, X-ray, MRI, ultrasound imaging or otherdetection means. When this preliminary examination reveals a suspiciousmass, the mass must be evaluated by taking a biopsy in order todetermine whether the mass is malignant or benign. Early diagnosis ofbreast cancer, as well as other forms of cancer, can prevent the spreadof cancerous cells to other parts of the body and ultimately preventfatal results.

A biopsy of the breast, for example, can be performed by either an openprocedure or a percutaneous method. The open surgical biopsy procedurefirst requires localization of the lesion by insertion of a wire loop,while using a visualization technique, such as X-ray or ultrasound.Next, the patient is taken to a surgical room where a large incision ismade in the breast, and the tissue surrounding the wire loop is removed.This procedure causes significant trauma to the breast tissue, oftenleaving disfiguring results and requiring considerable recovery time forthe patient. This is often a deterrent to patients receiving the medicalcare they require. The open technique, as compared to the percutaneousmethod, presents increased risk of infection and bleeding at the samplesite. Due to these disadvantages, percutaneous methods are oftenpreferred.

Percutaneous biopsies have been performed using either fine needleaspiration or core biopsy in conjunction with realtime visualizationtechniques, such as ultrasound, mammography (X-ray), MRI, PET, CT,terahertz technologies, etc. Fine needle aspiration involves the removalof a small number of cells using an aspiration needle. A smear of thecells is then analyzed using cytology techniques. Although fine needleaspiration is less intrusive than an open procedure, only a small amountof cells are available for analysis. In addition, this method does notprovide for a pathological assessment of the tissue, which can provide amore complete assessment of the stage of the cancer, if found. Incontrast, in core biopsy a larger fragment of tissue can be removedwithout destroying the structure of the tissue. Consequently, corebiopsy samples can be analyzed using a more comprehensive histologytechnique, which indicates the stage of the cancer. In the case of smalllesions, the entire mass may be removed using the core biopsy method.For these reasons core biopsy is preferred, and there has been a trendtowards the core biopsy method, so that a more detailed picture can beconstructed by pathology of the disease's progress and type.

The first core biopsy devices were of the spring advanced, “Tru-Cut”style consisting of a hollow tube with a sharpened edge that wasinserted into the breast to obtain a plug of tissue. This devicepresented several disadvantages. First, the device would sometimes failto remove a sample, therefore, requiring additional insertions. This wasgenerally due to tissue failing to prolapse into the sampling notch.Secondly, the device had to be inserted and withdrawn to obtain eachsample, therefore, requiring several insertions in order to acquiresufficient tissue for pathology.

Vacuum assisted core biopsy devices were subsequently developed thatrequired only a single insertion into the biopsy site to remove multipletissue samples. An example of a vacuum assisted core biopsy deviceincorporates a tube within a tube design that includes an outer piercingneedle having a sharpened end for piecing the tissue. The outer tube hasan opening for receiving tissue. An inner tube is slidingly disposedwithin the outer tube, and serves to cut tissue that has prolapsed intothe opening in the outer cannula. A vacuum is used to draw the tissueinto the opening in the outer cannula.

Vacuum assisted core biopsy devices are available in handheld (for usewith ultrasound) and stereotactic (for use with X-ray) versions.Stereotactic devices are mounted to a stereotactic unit that locates thelesion and positions the needle for insertion. In preparation for abiopsy using a stereotactic device, the patient lies face down on atable and the breast protrudes from an opening in the table. The breastis then compressed and immobilized by two mammography plates. Themammography plates create images that are communicated in real-time tothe stereotactic unit. The stereotactic unit then signals the biopsydevice and positions the device for insertion into the lesion by theoperator.

In contrast, when using the handheld model, the breast is notimmobilized. Rather the patient lies on her back and the doctor uses anultrasound device to locate the lesion. The doctor must thensimultaneously operate the handheld biopsy device and the ultrasounddevice.

While the vacuum assisted core biopsy device presented an advancement inthe field of biopsy devices, several disadvantages remain with some ofthe currently marketed devices. For example, when using the currentbiopsy devices, physicians have encountered significant difficultiessevering the tissue. For instance, the inner cutter often fails tocompletely sever the tissue. When the inner cutting needle is withdrawn,no tissue sample is present (dry tap), and therefore, reinsertion isrequired. In the case of the vacuum assisted core biopsy devicedescribed above, the failure to completely sever the tissue after thefirst advancement of the inner cutter results in a necessary secondadvancement of the inner cutter. In this event, the procedure isprolonged, which is significant because the amount of trauma to thetissue and, ultimately, to the patient is greatly affected by the lengthof the procedure. Therefore, it is in the patient's best interest tominimize the length of the procedure by making each and every attempt atcutting the tissue a successful and complete cut.

In light of the foregoing disadvantages, a need remains for a tissueremoval device that reliably applies a vacuum without becoming pluggedwith blood and bodily fluids. A need also remains for a tissue removaldevice that is entirely disposable so that both exposure to bio-hazardand clean-up time are significantly minimized, while convenience ismaximized. A further need remains for a tissue removal device thatcompletely severs the maximum amount of tissue without requiringnumerous attempts at cutting the tissue. A need also remains for atissue removal device that is compatible with multiple imagingmodalities. Finally, a need remains for a biopsy tissue removal devicethat is easy to use and does not cause a surgeon strain during use, butprovides satisfactory access to a lesion to be biopsied.

BRIEF SUMMARY

A surgical device is disclosed. The surgical device comprises a housing,a cutting element, a spool, a piston, and a spring. The cutting elementextends from the housing at the distal end of the housing. The cuttingelement comprises an outer cannula and an inner cannula. The spool isengaged with the outer cannula. The piston is engaged with the innercannula. A spring is positioned between the spool and the piston. Thespool is translated distally to translate the outer cannula towards thedistal end. And the piston translates the inner cannula towards thedistal end to sever tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the invention will beapparent from the following detailed description and the appendedclaims, taken in conjunction with the accompanying drawings, in which:

FIG. 1 is a perspective view of a surgical device, according to arepresentative embodiment of the disclosure.

FIG. 1A is a schematic view of a surgical system for use with thesurgical device of FIG. 1.

FIG. 1B is an enlarged view of an alternative embodiment of a distal endof the surgical device of FIG. 1.

FIG. 2 is a cross-sectional view of a portion of the surgical devicetaken along lines 2-2 in FIG. 1.

FIG. 3 is a perspective cross-sectional view of the surgical deviceshown in FIG. 1.

FIG. 4 is a cross-sectional view of an outer cannula of the surgicaldevice of FIG. 1 in a cocked position (top) and a fired position(bottom).

FIG. 5 shows side views of different length introducer cannulas.

FIG. 6A shows cross-sectional views of tissue prolapsed through asampling aperture formed in the outer cannula shown in FIG. 4 usingdifferent length introducer cannulas.

FIG. 6B shows cross-sectional views of resected tissue using differentlength introducer cannulas.

FIG. 7 is a cross-sectional view of surgical device of FIG. 1.

FIG. 7A is a partial enlarged cross-sectional view of the front of thesurgical device taken from encircled area 7A of FIG. 7

FIG. 7B is a partial enlarged cross-sectional view of a center sectionof the surgical device taken from encircled area 7B of FIG. 7.

FIG. 7C is a partial enlarged cross-sectional view of the rear of thesurgical device taken from encircled area 7C of FIG. 7.

FIG. 7D is a cross-sectional view of a seal shown in FIG. 7.

FIG. 7E is a perspective view of a rotator which is used with thesurgical device of FIG. 1.

FIG. 7F is a cross-sectional view of the rotator of FIG. 7E.

FIG. 7G is a perspective view of a vacuum attachment for use with therotator of FIG. 7E.

FIG. 8A is a cross-sectional view of an introducer hub.

FIG. 8B is a cross-sectional view of an introducer system for use withthe surgical device of FIG. 1.

FIG. 8C is a partial cross-sectional view of an introducer system, anintroducer cannula and an introducer hub.

FIG. 9A is a perspective view of an adapter for use with the surgicaldevice of FIG. 1.

FIG. 9B is a side view of the adapter of FIG. 9A.

FIG. 9C is a perspective view of a trocar holder for use with thesurgical device of FIG. 1.

FIG. 9D is a side view of the trocar holder of FIG. 9C.

FIG. 9E is a perspective view of the trocar holder of FIG. 9C and theadapter of FIG. 9A.

FIG. 9F is a side view of the trocar holder and the adapter of FIG. 9E.

FIG. 9G is a side view of the trocar holder and the adapter of FIG. 9Ewith a trocar positioned within the trocar holder.

FIG. 9H is a perspective view of an introducer attached to the adapterof FIG. 9A.

FIG. 9I is a side view of a breast in compression.

FIG. 10A is a perspective cross-sectional view of an air motor.

FIG. 10B is a side cross-sectional view of the air motor of FIG. 10A.

FIG. 11A is a perspective view of a remote valve according to anembodiment.

FIG. 11B is a perspective view of the remote valve of FIG. 11A in atubing arrangement for use with the surgical device of FIG. 1.

FIG. 12A is a cross-sectional view of remote valve in a cocked position.

FIG. 12B is a cross-sectional view of remote valve in an intermediateposition.

FIG. 12C is a cross-sectional view of remote valve in a fired position.

FIG. 13A is a cross-sectional view of an alternative embodiment of aremote valve in a cocked position.

FIG. 13B is a cross-sectional view of an alternative embodiment of aremote valve in a fired position.

FIG. 14 is a cross-sectional view of the surgical device of FIG. 1 in afired position with the inner cannula retracted.

FIG. 15 is a cross-sectional view of the surgical device of FIG. 1 in afired position with the inner cannula advanced.

FIG. 16 illustrates a general process flow for using the surgical deviceof FIG. 1.

FIG. 17 illustrates a general process flow for using a trocar holder ofFIG. 9 and the surgical device of FIG. 1.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Referring to the drawings, illustrative embodiments are shown in detail.Although the drawings represent the embodiments, the drawings are notnecessarily to scale and certain features may be exaggerated to betterillustrate and explain an innovative aspect of an embodiment. Further,the embodiments described herein are not intended to be exhaustive orotherwise limit or restrict the invention to the precise form andconfiguration shown in the drawings and disclosed in the followingdetailed description.

Overview

A tissue removal device used for breast biopsy is attached to astereotactic table for positioning. A patient's target area for tissueremoval is immobilized (e.g., a breast) in relation to the tissueremoval device. The stereotactic table allows precise positioning of abiopsy device, or any other device, at a known target area. Moreover,the stereotactic table allows for visualization of a known location forconfirmation or for providing a three-dimensional location futureanalysis and/or treatment. In many cases, the tissue removal device is asurgical device, such as is described in detail below and in thedrawings.

The device may include an adapter for mounting the surgical device to apositioning system, for example, a stereotactic table. However, thesurgical device may also be used with other positioning systems. In sucha case, the adapter may be configured to engage both the positioningsystem and the surgical device. In an example, a Lorad® bracket may beused to attach the device to a Lorad® table.

When the surgical device is installed with a positioning system,movements of the positioning system allow for the precise removal oftissue samples. Moreover, a surgeon may use one or many visualizationsystems (i.e., imaging modalities) to further identify a target area andthen precisely position the surgical device to remove tissue at thetarget area. The imaging modalities include, for example, MRI, PET, CT,ultrasound, terahertz technologies, etc. The location of the target areais determined and the position is recorded for manual or automaticmovement of the positioning system and the surgical device.

An introducer cannula is positioned and inserted into the patient toprovide a pathway to the target location, in one example using aseparate “stylet” to pierce the patient's tissue. The stylet, which isinserted through the introducer cannula and moved into the patient withthe introducer cannula, is removed from the introducer cannula aftercreating the pathway. The surgical device is then inserted through theintroducer cannula and into the pathway to the target site. Once thesurgical device is positioned, the tissue cutting portion of the devicethat is part of the surgical device is thereby positioned within thepatient close to the target site. In a blunt tip embodiment of thesurgical device, once the surgical device is positioned within thepathway, the device is ready to resect tissue samples.

In another embodiment with a trocar tip, the introducer cannula may bedisposed over an outer cannula of the surgical device. The trocar tipmay be used to create the pathway for the surgical device.Alternatively, the stylet may also be used, as described above. Once theinserted into the patient, the tissue cutting portion is then fired to afinal distance to the target site and tissue is resected (i.e., severedremoved from the patient). The resected tissue may be used for diagnosisof the possible pathologic condition or tissue may be debulked to removethe target area in its entirety.

In use, for example, the surgical device may be activated by usingremote valves. In another example, the surgical device is operated usinga remote valve to fire the tissue cutting portion into the patient tothe final position and a console pedal is used to perform the biopsyfunctions.

Before, during, or after tissue is removed, one or more treatments mayalso be introduced at the target site. Such treatments includebrachytherapy and other adjuvant treatments (such as, ablating tissue,heating tissue, freezing tissue, applying chemicals to tissue, externalbeam HIFU therapy, interstitial HIFU therapy, electroporation therapy,ultrasonicporation therapy, interstitial microwave therapy, etc.).Examples of such adjuvant treatments are described in co-pending U.S.patent application Ser. No. 11/550,209, entitled “SYSTEM AND METHOD FORMINIMALLY INVASIVE DISEASE THERAPY,” filed Oct. 17, 2006 by Joseph L.Mark, the contents of which are included in their entirety herein.

Referring now to the drawings, FIG. 1 shows a surgical device 100.Surgical device 100 includes an outer sleeve 102, an introducer cannula104, and a rotator 106. Further, surgical device 100 is positioned on acradle top 114. An adapter 112 connects cradle top 114 to a bracket 110.In an embodiment, surgical device 100 including outer sleeve 102,introducer cannula 104, rotator 106, and cradle top 114 are disposable.Adapter 112 is positioned underneath surgical device 100 (explained indetail below with respect to FIGS. 7, 9A, and 9E) and is typically leftattached to a positioning table for reuse with another surgical device100. A latch lever 108 is operable to release cradle top 114 fromadapter 112. Outer sleeve 102 is a housing that is provided to holdmoving components and seals internal to surgical device 100 and betweena proximal cap 120 and a front cap 124. Introducer cannula 104 is fixedto an introducer hub 126 that removably attaches cutting element 132 andadapter 112. During a procedure, introducer cannula 104 is positioned toallow for the insertion of surgical device 100 near the target site.When surgical device is positioned, a cutting element 132 protrudes(shown here in a fired position and explained below in detail withrespect to FIG. 4) at a distal end 130 of introducer cannula 104. In oneembodiment, cutting element 132 also includes a trocar tip 134 that isdesigned to easily penetrate tissue with minimal damage.

Alternatively, in one embodiment, cutting element 132 may include ablunt tip end (see FIG. 1B) that is not sharp (i.e., has a blunt tip).The blunt tip embodiment, which may include a generally hemisphericalshape, is useful where the site of interest is close to the back plateof the compression device as the trocar tip may extend too far and exitthe opposite side of the breast from the insertion point (as seen inFIG. 9I). Use of a cutting element 132 having a blunt tip end will bedescribed in further detail below in connection with FIG. 9.

Referring now to FIG. 1A, a schematic view of a surgical system 192 foruse with surgical device 100 is shown. Surgical system 192 includes aconsole 194, a remote valve 800, a user 196, and surgical device 100.User 196 is typically a surgeon and is able to control each of console194, remote valve 800, and surgical device 100. Console 194 provides airpressure and vacuum, as well as control logic, to surgical device 100.Surgical device 100 is primarily controlled by user 196 at remote valve800 during the high patient stress time of firing the cannula (for thoseembodiments with a trocar tip distal end), which is conveniently locatedbetween surgical device 100 and console 194.

Referring back to FIG. 1, a saline line 154, a firing line 152, a motorline 150, and a biopsy line 156 are attached to the surgical device.Lines 150-156 are also attached to a control console (not shown) forcontrolling surgical device 100. Cradle top 114 is a housing thatreceives, secures, and covers the internal attachment of saline line154, firing line 152, motor line 150, and biopsy line 156. Cradle top114 may be constructed of plastic or other suitable materials. In therepresentative embodiment shown, bracket 110 is configured as a “Fisher”style bracket and attaches to adapter 112 by a screw. The shown bracket110 is engaged or disengaged from a stereotactic table by rotatingattachment wheel 142. It is appreciated, however, that the bracket 110may be of other suitable configurations to permit use of the surgicaldevice with other surgical tables.

Rotator 106 includes a fitting 140 where a vacuum line attaches toprovide vacuum to cutting element 132. A rotation indicator 122 may beprovided that describes the rotary position of cutting element 132.Rotation indicator 122 is a window that is cut through outer sleeve 102so as to expose an inner portion having indicia that rotates along withrotator 106. In general, when rotator 106 is turned by a user, therotary position of cutting element 132 is shown by rotation indicator122. Typically, a numeral is shown at rotation indicator 122 describingthe position of cutting element 132 in a manner similar to a clock face.For example, the indicia of rotation indicator 122 may include numeralssuch as one (1) through twelve (12) o'clock. In this way, a surgeon canimmediately and intuitively determine the rotary position of cuttingelement 132 by viewing rotation indicator 122. Moreover, rotationindicator 122 is highly visible and does not require special training todetermine the angular position of cutting element 132. Alternatively,any indicia may be used for rotation indicator 122 to indicate theposition of cutting element 132.

The components of surgical device 100 are configured such that theturning of rotator 106 is not overly burdensome on the operator (e.g., asurgeon). Thus, the torque required to turn rotator 106, and necessarilycutting element 132 including a sampling aperture 250 (see FIG. 4), islow. Thus, low grip strength and low torque is required to turn rotator106 and cutting element 132. The low torque requirements are partiallyattributable to a floating o-ring design of the internal components(described below in detail with respect to FIG. 7D), a cup seal designor a combination of both.

FIG. 2 is a cross-sectional view of introducer cannula 104 taken alonglines 2-2 of FIG. 1. As may be seen, an outer cannula 160 and an innercannula 162 are disposed within introducer cannula 104. Cutting element132 (see FIG. 1, and described below in detail with respect to FIG. 6)is a tube-within-a-tube arrangement that includes outer cannula 160 andinner cannula 162. When tissue is severed, a vacuum is pulled frominside inner cannula 162 at a sample lumen 166 where fluid and tissueare taken away and expelled at fitting 140 for collection in a tissuefilter container. Moreover, saline or other therapeutics may beintroduced to the target site through a gap 164 between outer cannula160 and inner cannula 162.

FIG. 3 is a perspective cross-sectional view of surgical device 100shown in FIG. 1. A holding screw 170 connects bracket 110 to adapter112. Attachment wheel 142 is turned by the user to tighten bracket 110onto a positioning system or a stereotactic table. However, bracket 110is an optional component of surgical device 100. Thus, adapter 112 maybe mounted directly to a positioning system or stereotactic table, andthus capable of receiving surgical device 100. When using bracket 110,locating pins 172 are mounted to bracket 110 and are used to locateadapter 112 with respect to bracket 110 along with holding screw 170.Adapter 112 is positively located on locating pin 172. When holdingscrew 170 is tightly engaged with adapter 112, the two parts are fixedlyattached. Thus, when bracket 110 is moved (typically being attached to amovable table), then adapter 112 and surgical device 100 are also movedin unison.

Surgical device 100 itself may be disengaged from adapter 112 by pullingup on latch lever 108, which in turn disengages a latch 180 (describedin detail below with respect to FIG. 7C). In the normal course of use,adapter 112 is not removed from the positioning system or stereotactictable and multiple surgical devices 100 may be attached, used, andreplaced with new surgical devices 100 for other patients.

Housed within outer sleeve 102 is an inner body 190 that contains movingelements of surgical device 100. Within inner body 190, surgical device100 further includes an air motor 200 that is fixedly connected to innercannula 162 (see FIG. 2, not labeled in FIG. 3). In overview, air motor200 traverses within inner body 190 and acts as a piston to move innercannula 162 along its axis (explained below in detail with respect toFIGS. 14 and 15). Moreover, air motor 200 also rotates inner cannula 162to provide improved tissue cutting action. Both a traversal and arotation of inner cannula 162 are performed using fluid pressure (e.g.,air pressure) and are explained below in detail with respect to FIGS. 14and 15.

A spool 202 is connected to outer cannula 160. The spool fires orretracts outer cannula 160 as explained below in detail with respect toFIG. 4. Spool 202 traverses distally within inner body 190 by way ofspring force, which in turn traverses outer cannula 160 distally withinintroducer cannula 104 (explained below in detail with respect to FIGS.14 and 15). Spool 202 is traversed proximally using air pressure.

The fluid pressure is selectively presented at locations along outersleeve 102 at a biopsy port 210, a motor inlet port 212, and a firingport 216. The operation of each port 210, 212, 216 is described indetail below with respect to FIGS. 7-7C. In general, firing line 152 isconnected to firing port 216, motor line 150 is connected to motor inletport 212, and biopsy line 156 is connected to biopsy port 210.

Fitting 140 includes a glue well 220 or barb that is used to connect totubing that leads to a remote tissue collection canister (see FIG. 11B)or other tissue collection systems. When a vacuum is applied to innercannula 162, resected tissue is drawn through the length of innercannula 162 from cutting element 132 to tubing and the remote tissuecollection canister mentioned above. An example of a suitable collectioncanister and filter media is described in co-pending U.S. patentapplication Ser. No. 11/132,034, entitled “SELECTIVELY OPENABLE TISSUEFILTER,” filed Dec. 16, 2005 by Joseph L. Mark et al., the contents ofwhich are included in their entirety herein.

FIG. 4 shows cross-sectional views of outer cannula 160 in a cockedposition 240 (top view) and a fired position 242 (bottom view).Introducer cannula 104 with outer cannula 160 inserted in cockedposition 240 is used for initial positioning near a target site. Whenthe target site is located, typically using an imaging modality asdiscussed above, outer cannula 160 is rapidly thrust distally to firedposition 242. By quickly thrusting outer cannula 160 to the target site,the tissue is cleanly cut by trocar tip 134 and the target tissue is notmoved, pushed, or substantially damaged. When outer cannula 160 is infired position 242, a sampling aperture 250 is also positioned at thetarget site. As mentioned with respect to FIG. 1, turning rotator 106will also turn sampling aperture 250, which is part of cutting element132. In this way, a surgeon may sample from any angular direction andresect tissue at multiple locations. Inner cannula 162 is not shown forclarity, but is described in detail with respect to FIGS. 6A and 6B.

FIG. 5 shows side views of different lengths of introducer cannula 104(shown in FIG. 1), including a first introducer cannula 260 and a secondintroducer cannula 262. First introducer cannula 260 has a predeterminedlength of L1. Second introducer cannula 262 is longer overall and has apredetermined length of L2. When introducer cannulas 260 or 262 areattached to surgical device 100, distal ends 272, 280 extend away fromsurgical device 100 to different distances based on their respectivelengths, L1 and L2. By providing different length introducer cannulae,different aperture lengths may be created.

FIG. 6A shows cross-sectional views of tissue prolapsed through samplingaperture 250 using different length introducer cannulas 260 and 262. Inan embodiment 268 using first introducer cannula 260, having a lengthL1, distal end 272 protrudes minimally over sampling aperture 250. Whena vacuum is pulled at inner cannula 162, a first amount of tissue 274prolapses through sampling aperture 250 and is not substantially blockedby introducer cannula 260.

In a second embodiment 270, second introducer cannula 262 is used thathas a length L2 which is longer than length L1. Because the distancealong outer cannula 160 is fixed, second introducer cannula 262protrudes at distal end 280 partially over sampling aperture 250 andeffectively reduces the size of sampling aperture 250 resulting in areduced volume of prolapsed tissue 282 entering outer cannula 160. Thus,by using different length introducer cannulas 260, 262 a surgeon is ableto determine the effective sampling aperture of surgical device 100 byselectively limiting access to sampling aperture 250. It is contemplatedthat a length of introducer cannula 104 will leave sampling aperture 250entirely open, or the length may be configured to substantially closesampling aperture 250, or any length therebetween may control theeffective size of sampling aperture 250.

It is understood, that prior to taking a sample of tissue 274/282, innercannula 162 may be positioned so as to be disposed substantially flushto sampling aperture 250. However, in some situations (depending on avariety of factors), when inner cannula 162 is in this position, vacuumfrom inner cannula 162 may pull tissue into sampling aperture 250 priorto the cutting stroke. And, if this occurs, the drawn tissue may sealgap 164 between inner and outer cannulae 162 and 160, respectively,thereby creating a vacuum lock on any tissue in the cannula or similardiameter tubing. Thus, if this occurs, the excised tissue may beprevented from freely passing though the inner cannula 162.

FIG. 6B shows cross-sectional views of resected tissue using differentlength introducer cannulas 260 and 262. In both first embodiment 268 andsecond embodiment 270, inner cannula 162 is traversed distally androtated to assist in severing the tissue prolapsed through samplingaperture 250. In first embodiment 268, using first introducer cannula260, a large amount of resected tissue 284 is present within innercannula 162. In second embodiment 270, a smaller amount of resectedtissue 286 is present within inner cannula 162. The difference in volumeof tissue resected is related to the increased or decreased effectivesize of sampling aperture 250 and the resultant size of prolapsedtissue. Thus, different length introducer cannulas 260, 262 may be usedto control the size of tissue resected, and the length of the device tobe inserted into the patient. (For example, 270 is a “petite” aperturethat may be used on thin breasted women).

FIG. 7 is a cross-sectional view of surgical device 100 of FIG. 1. Forgreater detail of the inner components of surgical device 100, refer toFIGS. 7A-7C for the areas of enlargement as shown. By way of example,motor inlet port 212 provides pressure to the interior of inner body 190by way of a motor inlet pressure groove 314. Motor inlet pressure groove314, and the pressure applied, is sealed from the rest of inner body 190using a first annular seal 310 and a second annular seal 312 that aresurrounded by outer sleeve 102. Seals 310, 312 are typically o-rings andare configured as floating o-rings. Such groove and ring seal designsare also applied to biopsy port 210, motor exhaust 214, and firing port216, as explained below in detail with respect to FIG. 7D.

FIG. 7A is a partial enlarged cross-sectional view of the front ofsurgical device 100 taken from encircled area 7A of FIG. 7. Adapter 112further includes a wall portion 408 for holding surgical device 100 inplace along a front face of surgical device 100. Wall portion 408cooperates with latch lever 108 to retain surgical device 100. Further,wall portion 408 also provides an attachment point for introducer hub126. Introducer hub 126 includes a seal 410 that outer cannula 160 andinner cannula 162 protrude through. Additionally, introducer hub 126includes a lower portion 411 having a hub snap feature 412 that engageswall portion 408. As shown in FIG. 7A, hub snap feature 412 extends fromlower portion 411 and extends snaps onto wall portion 408. Hub snapfeature 412 may be configured to interfere with, snap into, orselectively engage with wall portion 408, such that wall portion 408holds introducer cannula 104 (which is attached to introducer hub 126)and introducer hub 126 in place.

The positioning of lower portion 411 proximal with wall portion 408provides registration of introducer hub 126 to adapter 112. Moreover,when surgical device 100 is selectively attached to adapter 112 and whenintroducer hub 126 is in place, registration and position relative toeach of adapter 112, surgical device 100, introducer hub 126, distal end130, and cutting element 132 is secured. Such registration allows forprecise positioning of cutting element 132 relative to adapter 112 andthe target area. Typically, adapter 112 is linked to a positioning tableallowing for precise positioning of adapter 112 and surgical device 100.Note that introducer hub 126 is independently attachable to wall portion408 such that introducer hub 126 may be left attached to wall portion408 when surgical device is disengaged from adapter 112 and removed fromadapter 112.

A first seal 420 and a second seal 422 engage outer cannula 160 toprevent leakage of pressure or fluids from surgical device 100. Outercannula 160 is slidably and rotatably free to move along its axis withrespect to first seal 420 and second seal 422, among other sealsdescribed below. Saline line 150 engages a connector 424 near the frontportion of surgical device 100. Connector 424 engages with a salinechannel 426 and is sealed with a saline o-ring 428. Saline channel 426is further sealed between first seal 420 and second seal 422 and allowsfor the flow of saline around outer cannula 160.

When outer cannula 160 is in the fired position (shown translateddistally in FIG. 6), a saline port 430 is advanced between first seal420 and second seal 422. Thus, when saline is forced or pulled by vacuumthrough saline line 154, through connector 424, saline channel 426,saline enters outer cannula 160 at saline port 430. Under pressure,saline travels distally along gap 164 between outer cannula 160 andinner cannula 162 (described above in detail with respect to FIG. 2).Upon reaching aperture 250 (shown above in detail with respect to FIG.6), the saline exits the aperture 250 and typically, depending uponplacement, flows at the target site. As discussed herein, saline line154 may be used to deliver liquids, including but not limited to saline,drugs, or treatments to the target site. In one embodiment, saline isinjected into the saline line 154. In another embodiment, a closedsystem is used such that saline is pulled via vacuum from the vacuumline to the inner cannula and back to the saline line.

FIG. 7B is a partial enlarged cross-sectional view of a center sectionof surgical device 100 taken from encircled area 7B of FIG. 7. Outercannula 160 is fixedly attached to spool 202 by glue (or other suitableadhesives, ultrasonic welding, insert molding, etc.). Thus, when spool202 moves, so does outer cannula 160. Also attached to spool 202 is aspring guide 460. A spring 462 sits within a spring cavity 464 andspring guide 460 prevents buckling of spring 462 when compressed andpreventing interference with inner cannula 162. As shown in FIG. 7B,spring 462 is compressed between spool 202 and air motor 200. Thefunction of spring 462 is described in detail below with respect toFIGS. 14 and 15.

An exhaust chamber 440 is an open space within inner body 190 allowingfor movement of air motor 200 distally when spool 202 has moved forward.When air motor 200 is active (by running pressure through the motorportion) air may exit, thereby creating flow, through motor exhaust 214.Additionally, a first seal 450 and a second seal 452 prevent airpressure from motor exhaust from escaping beyond an annular channel 454.

Distally, exhaust chamber 440 is sealed. In one embodiment a cup seal isused. In another embodiment, a ring 442 is seated in an annular groove444 in spool 202 and by an inner cannula seal 468. A seal 754 on airmotor 200 seals exhaust chamber 440 proximally. Inner cannula seal 468prevents saline flow back into the mechanism and forces the salinetoward the distal end of outer cannula 160 (discussed in detail withrespect to FIGS. 2 and 7).

FIG. 7C is a partial enlarged cross-sectional view of the rear ofsurgical device 100 taken from encircled area 7C of FIG. 7. Latch 180further comprises a latch tongue 470 that selectively engages a latchslot 472 formed at the proximal end of adapter 112. Pulling up on latchlever 108 disengages latch tongue 470 from latch slot 472 and allows theuser to remove surgical device 100 from adapter 112. When the userdesires to move air motor 200 distally (described in detail with respectto FIG. 15) air pressure enters at biopsy port 210 and fills biopsycavity 808. Seals 762 and an inner cannula seal 772 (see FIG. 10A)prevent the pressure from escaping distally and seals 816, 818 atproximal cap 120 prevents pressure from escaping proximally. Thus, whenbiopsy cavity 808 is pressurized, air motor 200 translates (e.g., moves)distally within surgical device 100.

Inner cannula 162 is sealed at a proximal cap 120 by an o-ring 818. Asdiscussed above, inner cannula 162 is glued (or otherwise fixedlyattached) to air motor 200. Thus, when air motor 200 is translated,inner cannula 162 also moves. O-ring 818 allows inner cannula 162 tomove while still maintaining a seal between proximal cap 120, biopsycavity 808, and inner cannula 162. Additionally, fitting 140 is sealedby an O-ring 820. An end of fitting 140 is sealingly received within adistal end of a vacuum line. Thus, when a vacuum is applied to thevacuum line, the vacuum is contained and pulled through sample lumen 166(see FIG. 2) of inner cannula 162 for removal of tissue and fluids fromthe target site.

Referring back to FIG. 7, an exhaust piston 320 includes seals 322 andengages firing port 216. Exhaust piston 320 is used to vent a frontchamber 434 distal from spool 202 and therefore allows for rapidmovement of spool 202 when desired. Exhaust piston 320 further includesa small hole (not shown) at the top of the piston allowing air topressurize through it. When the pressure in the open cavity distallyfrom spool 202 is greater than the pressure on the bottom of the piston,exhaust piston 320 will move away from firing port 216 and allow forrapid exhaust of gas. This reduced pressure on the bottom of the pistonis created by firing a remote valve (see FIGS. 11-13B).

FIG. 7D is a cross-sectional view of seal 310 (see also FIG. 7). Seal310 is cup seal that sits in a groove 830 on the outside of inner body190. In an alternative embodiment, seal 310 may be configured as afloating o-ring. In such an embodiment, a lateral space 832 and avertical space 834 allow the floating o-ring to move within groove 830.

When pressure is applied, seal 310 moves within groove 830 to sealagainst inner body 190 and outer sleeve 102. Both seal 310 and thefloating o-ring embodiments permit inner body 190 to be turned withinouter sleeve 102 without undue friction. Thus, the user may turn cuttingelement 132 and inner body 190 by light force using rotator 106 (seeFIG. 1). In addition to seal 310, seals 312 (see FIG. 7), 450, 452(shown in FIG. 7B), seal 814 (see FIG. 7C), as well as the other sealsbetween inner body 190 and outer sleeve 102 also may use floatingo-rings. Standard o-rings may also be used.

FIG. 7E is a perspective view of rotator 106 which is used with surgicaldevice 100. Proximal cap 120 is used to close off the proximal end ofsurgical device 100 and seals 816 prevent any pressure from escapingfrom inner sleeve 102 (see FIGS. 1 and 7C). A receiving portion 870receives fitting 140 (see FIGS. 1, 3, and 7G) that is pressed/snappedwithin receiving portion 870 to connect surgical device 100 to aflexible suction line and ultimately a tissue collection system.

FIG. 7F is a cross-sectional view of rotator 106. Seal 818 preventsleakage of pressure around the outer periphery of inner cannula 162 (seeFIGS. 2 and 7C). Receiving portion 870 is sized to receive fitting 140but also allow it to rotate. The rotation allows for the free turning ofcutting element 132, without complications caused by twisting of thesuction lines.

FIG. 7G is a perspective view of fitting 140 for use with rotator 106 ofFIG. 7E. Glue well or barb 220 receives a flexible vacuum line that isused to remove fluids, tissue, etc. from the target site.

FIG. 8A is a cross-sectional view of an embodiment of introducer hub 126that includes an outer body 700, an inner body 726, and a sealing member710. Outer body 700 and inner body 726 are typically constructed of agenerally rigid plastic material. Sealing member 710 is a flexible sheetmaterial suitable for sealing when perforated by trocar tip 134 (seeFIG. 1). Outer body 700 includes an inner interference portion 702 thatis held between an outer interference portion 722 and a needle guide 720of inner body 726. Sealing member 710 is then placed between needleguide 720 and inner interference portion 702. Glue, ultrasonic welding,snap fitting, or other suitable attachment mechanisms are used toprevent separation of outer body 700 and inner body 726.

FIG. 8B is a cross-sectional view of an introducer system 640. Used as asingle assembly with surgical device 100, introducer system 640 allowsprovides for entry, positioning, and placement of medical devices,treatments, and/or markers within a patient. A joining region 650sealingly connects introducer hub 126 to introducer cannula 104 to forma single generally rigid unit. In operation, trocar tip 134 protrudesjust beyond distal end 130 of introducer cannula 104 for insertionwithin the patient's body (see FIG. 4). When fired, cutting element 132extends beyond distal end 130 for tissue resection, lavage, delivery ofsaline or treatments, etc. (see FIG. 4). Moreover, when cutting element132 is removed from introducer system 640, introducer cannula 104remains within the patient with distal end 130 precisely positioned atthe target area. When surgical system 100 is removed from introducercannula 104, introducer system 640 may be used as a general purposeaccess port to the target area. Moreover, sealing member 710 functionsas a valve to reduce or prevent leakage of fluids from the patientthrough introducer cannula 104. A clip-on feature 652 allows forremovable placement of introducer system 640 onto a positioning table.

FIG. 8C is an enlarged partial cross-sectional view of introducer system640, introducer cannula 104 and introducer hub 126. Clip-on feature 652includes finger actuators 654 and retaining clips 656. These allow theuser to easily position and selectively remove introducer system 640from adapter 112. The interaction with adapter 112 is described indetail below with respect to FIGS. 9A-9I. After introducer system 640 ispositioned on adapter 112, trocar tip 134 is pushed through a proximalopening 660 and easily penetrates sealing member 710 when insertedtherethrough. Sealing member 710 then closes against the outer peripheryof outer cannula 160. If surgical device 100, including outer cannula160 are removed, sealing member 710 is biased to a normally closedposition to prevent fluids from escaping through sealing member. In oneembodiment, sealing member by be pre-slit prior to trocar tip 134 beinginserted therethrough.

FIG. 9A is a perspective view of adapter 112 for use with surgicaldevice 100 of FIG. 1. FIG. 9B is a side view of adapter 112. Adapter 112includes a surface 480 and a rail portion 476. The bottom edges ofsurgical device 100 engage with rail portions 476. Surgical device 100then slides along surface 480 when surgical device is engaged with orremoved from adapter 112. Latch tongue 470 of surgical device 100selectively engages latch slot 472 (see FIG. 7C). Pulling up on latchlever 108 disengages latch tongue 470 from latch slot 472 and allows theuser to remove surgical device 100 from adapter 112 (see FIG. 7C)locking the proximal end of surgical device 100 to adapter 112. When auser places surgical device 100 onto adapter 112, latch tongue 470 movesupwardly over a ramp 474 and engages latch slot 472 to securingly holdsurgical device 100 to adapter 112. Wall portion 408 acts as a stop andprevents surgical device 100 from further distal movement when loadedand latch 180 (including latch tongue 470 and latch slot 472) preventssurgical device 100 from moving proximally until latch 180 isdisengaged.

An introducer mounting system 490 includes wall portion 408 thatreceives introducer system 640 and provides a stable attachment pointfor clip-on features 652 of introducer hub 126 (described above indetail with respect to FIG. 8C, also shown in FIG. 9H). When introducersystem 640 is attached to wall portion 408, retaining clips 656 lock inplace around a mounting post 492 and introducer cannula 104 ispositioned above wall portion 408 at a stabilizing rest 494. In removingintroducer system 640 from introducer mounting system 490, the userpresses finger actuators 654 together which in turn unlocks retainingclips 656 from mounting post 492.

Adapter 112 may be attached to a positioning table by bracket 110 (seeFIGS. 1 and 3). Holes 482, 484, 486 are positioned along adapter 112 tofacilitate removable attachment of adapter 112 to bracket 110. Forexample, holding screw 170 connects with holes 486 (see FIG. 3) andlocating pins 172 connect with holes 484 and 488. A slot 488 may be usedto prevent overconstraining the adapter when attaching the adapter to astereotactic table.

FIG. 9C is a perspective view of a trocar holder 540 for use withsurgical device 100. FIG. 9D is a side view of trocar holder 540. Trocarholder 540 may be used to hold a trocar device 575 (See FIG. 9G) tofacilitate entry into a patient and create a pathway for surgical device100. Trocar 575 is particularly useful for embodiments of surgicaldevice 100 that have a cutting element 132 that includes a blunt tip,rather than a trocar tip 134.

Trocar holder 540 includes a pair of receiving grooves 542, 544 allowtrocar holder 540 to slide along adapter 112 (see FIGS. 9E and 9F). Anengagement member is selectively receivable 545 within groove 488 ofadapter. Trocar 575, which is separate from surgical device 100, allowsa user to pierce the patient's skin and locate introducer system 640 atthe target site before surgical device 100 is mounted to adapter 112.Trocar 575 may be used, for example, for thin-when-compressed breastswhere the firing mode of surgical device 100 may pose a risk of passingthrough the breast entirely when the breast is compressed and in caseswhere the lesion of interest is positioned near the back plate of thestereotactic table. (see FIG. 9I). In such cases, surgical device 100includes a blunt tip (rather than trocar tip 134 of FIG. 1). Referringto FIG. 9G, in operation, trocar 575 is loaded onto trocar holder 540.The trocar is pushed through introducer system 640 (which is locked onto the end of adapter 112) locked onto adapter at 488 and is manuallymoved to pierce through the patient's tissue.

The external trocar locks into a pair of seats 550, 552, and spring clip570 (see FIG. 9C) and is held in place axially (see FIG. 9G). A holderbody 560 separates grooves 542, 544 (located at the bottom of trocarholder 540) and seats 550, 552 such that the external trocar is held atthe correct height to interface with introducer cannula 104. Adirectional indicator 562 may be provided to show the user whichdirection holder body 560 is to be placed on adapter 112 (e.g., thearrow points in the direction of the patient).

FIG. 9E is a perspective view of trocar holder 540 in use with adapter112, FIG. 9F is a side view of trocar holder 540 in use with adapter 112and FIG. 9G is a side view of trocar holder 540 with trocar 575 insertedtherein. A clip 570 sits within key 554 to hold the external trocarsecuringly in place. Thus, a user may insert the trocar by pushing downupon clip 570 with the trocar and it will snap into place into a groove573 formed on trocar 575. In one embodiment, trocar holder 540 andtrocar 575 are designed such that trocar 575 may only fit into trocarholder 540 in the desired configuration. To remove trocar 575 the usermay pull up on the trocar to disengage clip 570. In use, external trocar575 sits on trocar holder 540 and is aligned with the inner lumen ofintroducer cannula 104 that sits atop stabilizing rest 494. A pushbuttonrelease 572 allows the user to disengage engagement member 545 of trocarholder 540 from adapter 112 so that surgical device 100 may then beinstalled upon adapter 112 for use.

FIG. 10A is a perspective cross-sectional view of air motor 200. Anexample of an air motor 200 and the function thereof is described indetail with respect to co-pending U.S. patent application Ser. No.11/058,128, entitled “SINGLE MOTOR HANDHELD BIOPSY DEVICE,” filed Feb.15, 2005 by Michael E. Miller, the contents of which are incorporated byreference in its entirety. In general, air motor 200 includes sealingcaps 750A, 750B, motor vanes 752, a front seal 754, a first rear seal760, and a second rear seal 762. Front seal 754 is seated in a frontannular channel 756 and is used to seal sealing cap 750A with inner body190 to create an air motor supply cavity 768 with first rear seal 760.Second rear seal 762 is seated in a rear annular channel 764 and sealssealing cap 750B with inner body 190 to create biopsy cavity 808 (seeFIG. 7C). Seals 754, 760, and 762 are embodied as cup seals to improvesealing under certain pressures while still maintaining low friction inmotion. However, other known seals, such as o-rings, may also be used.

When first rear seal 760 and front seal 754 are under a pressure appliedfrom operating air motor 200, seals 760 and 754 will expand due to thecup seal configuration. Thus, sealing will be improved when air motor200 is pressurized. Because biopsy cavity 808 is also selectivelypressurized, second rear seal 762 will also expand and provide improvedsealing.

Air motor 200 further includes a pass-through 770 for inner cannula 162to extend through. Inner cannula 162 extends from cutting element 132(see FIG. 1), through air motor 200, to fitting 140. Additionally, innercannula 162 is fixedly attached to air motor 200 by glue or othersuitable material in passthrough 770. Additionally, an inner cannulaseal 772 is used to seal air motor 200 with inner cannula 162. Sealingcap 750A further includes a spring guide 778 and sealing cap 750Bfurther includes a rear face 774. Air motor 200 also includes a rotor780, explained in detail below with respect to FIG. 10B, that providesfor rotary motion of inner cannula 162. As shown in FIG. 7C, rear face774 forms a movable boundary for biopsy cavity 808. Thus, when biopsycavity 808 is sufficiently pressurized, the force applied to rear face774 translates air motor 200 distally. Alternatively, when biopsy cavity808 is vented, spring 462 (see FIG. 7B) translates air motor 200proximally. Thus, air motor 200 provides a rotary motion to innercannula 162, as well as translation distally and proximally.

FIG. 10B is a side cross-sectional view of the air motor of FIG. 10A. Amotor outer housing 790 contains rotor 780 that is configured to spinwith the addition of air pressure as a power source. Rotor 780 includesvanes 752. Rotor is attached to inner cannula 162 by glue or by apress-fit. When air pressure is supplied to air motor 200, vanes 752 androtor rotate about the axis of inner cannula 162 and by virtue of theirattachment, also rotate inner cannula 162. A distal bearing 793 and aproximal bearing 795, e.g. ball bearings or roller bearings, allow rotorand vanes 752 to rotate within motor outer housing 790. A distal motorend cap 792A and a proximal motor end cap 792B provide backing fordistal bearing 793 and a proximal bearing 795 to ride between. Distalmotor end cap 792A and a proximal motor end cap 792B also seal motorouter housing 790 at each end, providing an air-tight cavity for vanes752 to rotate within.

FIG. 11A is a perspective view of remote valve 800. Remote valve 800includes a firing button 802, a cocking button 804, an actuator rod 806,a remote valve body 810, and finger bars 812. Air pressure from aconsole (not shown) enters remote valve 800 at console inlet 814. Firingline 152 (see FIG. 1) is sealingly engaged to firing port 828. Biopsyline 156 (see FIG. 1) is sealingly engaged to biopsy port 826. Whenfiring button 802 is pressed toward remote valve body 810, pressure isvented from firing port 828 and firing line 152 and outer cannula 160 israpidly extended distally (described in detail with respect to FIGS. 4,14, and 15). Pressure is then applied to biopsy port 826 and biopsy line156. When cocking button 804 is pressed towards remote valve body 810,pressure is vented from biopsy port 826 and biopsy line 156 and pressureis then applied to firing port 828 and firing line 152.

FIG. 11B is a perspective view of remote valve 800 in a tubingarrangement for use with surgical device 100. An aspiration line 920 isconnected to glue well 220 and ultimately to inner cannula 162 (see FIG.3). Aspiration line 920 provides vacuum from console 194 and is used topull fluids, tissue, and/or generally remove irrigation from the targetsite. A removable tissue filter canister 922 is connected in-line withaspiration line 920 where harvested tissue may be collected foranalysis. Console inlet 814 (see also FIG. 11A) is connected to apressure line 928 which is controlled by console 194.

Saline line 154 is connected to surgical device 100 (see FIG. 1) and toa selectively closable valve that may include a stopcock 890 or afitting (i.e., a luer lock) that may be selectively opened and closed. Asaline port 892 is associated with stopcock 890. Saline port 892connects to a saline source (e.g., a saline bag) but may also beconnected to other types of liquid sources such as bag containing atreatment fluid. Saline line 150 may also include an injection port 894that allows a user to inject substances to be transported to the targetsite. In one example, a user may inject an anesthetic into injectionport 894 and the anesthetic may be transported to the target site alongwith saline or alone. Stopcock 890 may also be selectively activatedclose-off the saline source from saline port 892 allowing saline line150 to be vented to the atmosphere through an atmospheric line 896. Thisallows the user to selectively aspirate the target site, aspiration line920, and collection canister 922, for example, after tissue is resectedto remove fluids from the system.

FIG. 12A is a cross-sectional view of remote valve 800 in a cockedposition 840. Remove valve 800 includes a first port 850, a second port852, a third port 854, a fourth port 856, and a fifth port 858. Firstport 850 and fifth port 858 are connected to firing port 828 and firingline 152. First port 858 also includes a one-way check valve that doesnot allow pressure from firing line 152 to flow into remote valve 800(also described with respect to FIGS. 13A and 13B). For example, if theconsole is turned off or inlet air to remote valve 800 is removed, thenthe check valve will keep the device in the cocked position. Second port852 is connected to console inlet 814 and a pressure source. Third port854 is connected to biopsy port 826 and biopsy line 156. Fourth port 856is open to the atmosphere and serves as a vent.

Actuator rod 806 extends through remote valve 800 and includes a firstseal 848, a second seal 846, a third seal 844, and a fourth seal 842.Seals 846 and 848 may be configured as o-rings. Seals 842 and 844 may beconfigured as quad-rings (or four-lobed rings having parting lines awayfrom the sealing surface) to prevent pressurized air from first port850, and third port 854 from venting as seals 842, 844 pass over them.As actuator rod 806 is traversed through remote valve body 810, seals842, 844, 846, 848 create air flow regions for ports 858, 856, 854, 852,850 to selectively connect to each other or vent to the atmosphere tocontrol operation of surgical device 100. As shown in FIG. 12A, remotevalve 800 is in a cocked position 840 where second port 852 is connectedto first port 850 by way of seals 842 and 844 that and cavity 857between actuator rod 806 and remote valve body 810. Cocked position 840provides that air motor 200 and spool 202 are in their proximal mostpositions within surgical device 100 (see FIG. 3). If the console wereturned off while surgical device 100 was in the cocked position, airwould remain in exhaust chamber 440 (see FIG. 7B) and surgical devicewould remain in the cocked position until remote valve 800 were furthermanipulated due to the check valve.

FIG. 12B is a cross-sectional view of remote valve 800 in anintermediate position 860 between cocked position 840 (see FIG. 12A) anda fired position 870 (see FIG. 12C). Seal 842 is positioned over firstport 850. Second port 852 is effectively isolated by first seal 842 andsecond seal 844. Moreover, first seal 848 is prepared to disengage fromthe inner periphery of remote valve body 810 and become free to thesurrounding atmosphere (see FIG. 12C below).

FIG. 12C is a cross-sectional view of remote valve 800 in fired position870. First seal 848 is open to the atmosphere resulting in fifth port858, firing port 828, and firing line 152 being exhausted. For example,port 858 is open to the atmosphere via passage 874 as first seal 848 isno longer contacting remote valve body 810. Fired position 870 contrastswith the embodiment of FIG. 12A where first seal 848 is in sealingcontact with remote valve body 810 and second seal 846 and first seal848 seal port 858 therebetween.

Because first seal 848 is an o-ring and is exhausted directly to theatmosphere across the entire circumference of the o-ring, rather thanthrough a port (see FIGS. 12A and 12B), a larger volume of air may beexhausted. Such a rapid exhaust assists in the rapid deployment, orfiring, of spool 202 and outer cannula 160 (see FIGS. 4 and 14).

Third port 854 is then connected to second port 852, console inlet 814,and a pressure source from a console (not shown). When third port 854and second port 852 are connected by virtue of first seal 842, secondseal 844 and cavity 872, pressure is applied to biopsy cavity 808 andair motor 200 is moved forward in biopsy mode slightly after spool 202is fired forward (described in detail below with respect to FIG. 15).

FIG. 13A is a cross-sectional view of an alternative embodiment of aremote valve 880 in a cocked position. Remote valve 880 includes a thumbtrigger 882, a pressure port 888, and a pressure channel 886. Thumbtrigger 882 is used to move a valve body 884 within remote valve 880.Valve body 884 further includes a first seal 904, a second seal 902, anda third seal 900. Port 912 and check valve 910 are connected to firingline 152. Vent ports 892 and 894 are open to the atmosphere. Check valve910 prevents pressure from firing line 152 from entering remote valve880. However, check valve 910 allows pressure from pressure port 888(connected to a console) to pressurize firing line 152. When in thecocked position, seals 900 and 902 prevent pressure from pressure port888 from escaping anywhere other than through check valve 910. Seals 902and 904 prevent port 912 from venting the pressure of firing line 152.

FIG. 13B is a cross-sectional view of an alternative embodiment of aremote valve 880 in a fired position. Thumb trigger 882 is moved forwardand thus, moves valve body 884. Port 912 is open to the atmosphere viavent 892. Thus, firing line 152 is also vented to the atmosphere. Then,pressure port 888 then pressurizes biopsy line 156 and is sealed byseals 900 and 902. The sequence is reversed to go from a fired to acocked position.

FIG. 14 is a cross-sectional view of surgical device 100 in the firedposition 510 with inner cannula 162 retracted. Air pressure is removedfrom firing line 152 which reduces pressure under exhaust piston 320.Exhaust piston 320 then moves downwardly and spool cavity 434 is ventedto the atmosphere. A rapid escape of pressure at firing port 216 allowsfor spring 462 to thrust spool 202 distally and fire outer cannula 160to the target site (see FIG. 4). Spring 462 is left in an extendedposition 522 and spool 202 is left in a fired position 512. Air motor200 is in a proximal position 514 without air pressure applied to biopsyline 156 and biopsy port 210. Thus, inner cannula 162 is also distallypositioned. The action of firing surgical device 100 is effected byremote valve 800 (described in detail with respect to FIGS. 11-12C, andshown in the fired position with respect to FIG. 12C).

FIG. 15 is a cross-sectional view of surgical device 100 in the firedposition 530 with inner cannula 162 advanced. Air pressure is applied tobiopsy port 210 and biopsy cavity 808 where the pressure moves air motor200 distally. A larger biopsy cavity 811 is created from the movement ofair motor 200 distally. Inner cannula 162 also moves distally by virtueof being fixed to air motor 200. In the distal position, tissue issevered at the target site (see FIG. 6B). The tissue is drawn proximallyalong inner cannula 162 which remains sealed by o-ring seal 816.Pressure applied to motor inlet 212 enables rotation of air motor 200 torotate inner cannula 162 when air motor 200 is advancing. The rotationof inner cannula 162 while the biopsy cutting operation is taking placeassists in providing a clean cut. When air motor 200 is activated forrotation, air pressure flows from motor inlet 212, through air motor200, and is vented to the atmosphere at motor exhaust 214. Pressureapplied to motor inlet 212 is via motor line 154 and is controlled by afoot switch (not shown) or directly from a console (not shown). When airmotor 200 is driven distally, spring 462 compressed to a compressedstate 538. The biopsy cycles between aperture open (FIG. 14) andaperture closed (FIG. 15).

FIG. 16 illustrates a general process flow 2000 for using an embodimentof surgical device 100. The process flow is an example of how surgicaldevice 100 may be used in a hospital and/or doctor's office. Each of thesteps, and their order, is merely exemplary of a typical usage ofsurgical device 100 and it is understood that deviations from generalprocess flow 2000 in the addition of steps, omission of steps,reordering of steps, and repetition of steps may be performed based onclinical needs or other criteria. A general process flow 3000 for usinga separate trocar 575 to create a pathway for cutting element 132 isshown in FIG. 17.

Referring now to FIG. 16, at step 2010, the sterile surgical device 100is unpackaged from sealed sterile shipping/storage packaging. Thepackage is removed from a storage area and placed into a console traydesigned to hold surgical device 100 and the associated tubing andconnectors prior to use. The console tray is typically designed to havea footprint that matches the packaging. The process then continues withstep 2015.

At step 2015, surgical device 100 is connected to console 194 (see FIG.1A). In general, console 194 provides air pressure and vacuum, as wellas control logic, for surgical device 100. A user connects saline line150, firing line 152, motor line 154, and biopsy line 156 to console194. Saline line 150 may also be connected externally from console 194to a saline bag. The process then continues with step 2020.

At step 2020, console 194 is powered on. Console 194 performs aself-test of it's internal systems in preparation for use with surgicaldevice 100. For example, inputs, outputs, vacuum and pressure systemsare tested for proper functionality. The process then continues withstep 2025.

At step 2025, surgical device 100 is tested using console 194. Aprotective sheath (not shown) is typically a plastic tube and is placedover outer cannula 160 (see FIG. 4) without introducer cannula 104 inplace. The protective sheath allows surgical device 100 to prime andtest the saline delivery and aspiration systems. In general, theprotective sheath allows a vacuum to be achieved within the system. Theprotective sheath is typically already placed over outer cannula 160when shipped. Thus, the user typically confirms that the protectivesheath is in place rather than placing it on separately. A “setup” modebutton is pressed on console 194 to begin the testing process. Theentire system is then primed with saline, including surgical device 100.Saline is pulled through outer cannula 160 and sucked into inner cannula162 using aspiration vacuum. The saline is then pulled through theremovable filter/collection canister 922 (see FIG. 11B). The user maythen view collection canister 922 filling with saline to show that thesystem and surgical device 100 are working properly. The process thencontinues with step 2030

At step 2030, the sheath covering the outer cannula is removed uponcompletion of testing surgical device 100, console 194, and the salinesystem. The process then continues with step 2035.

At step 2035, the introducer system, including introducer cannula 104and introducer hub 126 (see FIG. 1), is placed over outer cannula 160.An example of an introducer cannula 104 is described in co-pending U.S.patent application Ser. No. 10/649,068, entitled “INTRODUCTION SYSTEMFOR MINIMALLY INVASIVE SURGICAL INSTRUMENTS,” filed Aug. 27, 2003 byJoseph L. Mark et al., the contents of which are included in theirentirety herein. Alternatively, the introducer system may be locked intovertical portion 408 of adapter 112 (see FIGS. 7A and 17). The processthen continues with step 2040.

At step 2040, surgical device 100 is cocked. Remote valve 800 is set tothe cocked position (shown in FIG. 12A). The process then continues withstep 2045. This step may also be performed after surgical device 100 ismounted in step 2045.

At step 2045, surgical device 100 is mounted to adapter 112 which inturn is mounted on a movable portion of a stereotactic table. Surgicaldevice 100 is secured onto adapter 112 and latch 180 is engaged withadapter 112 for positive attachment (see FIG. 3). The mounting isperformed by sliding surgical device 100 onto the rail portion 476 ofadapter 112 (see FIG. 17). The process then continues with step 2050.

At step 2050, a needle guide (used to stabilize introducer cannula 104)is advanced toward the patient. For example, in the case of a breastbiopsy the needle guide is advanced toward the patient's breast. Thiscan be accomplished manually or by using the stereotactic tablepositioning controls. For example, using table controls to advance theneedle guide includes enabling the table's motor and then inputting theappropriate X/Y location. The process then continues with step 2055.

At step 2055, the location of the target site is verified. Typically,stereotactic location pairs (e.g., two or more images taken fromdifferent angles) are used to confirm the location of introducer cannula104 relative to the target site. Once the target location is confirmed,the process then continues with step 2060.

At step 2060, surgical device 100 is positioned given the Z-location ofthe target site. Typically, the Z location is a manual adjustment madeby the user. Z positioning is stopped short by the exact distance of thefiring stroke of surgical device 100. That is to say, the position ofintroducer cannula 104 is advanced to a position where, when outercannula 160 is fired; the center of aperture 250 (see FIG. 4) isprecisely located at the target site. The process then continues withstep 2065.

At step 2065, outer cannula 160 is fired to the target site. Surgicaldevice 100 is fired using remote valve 800. Outer cannula 160 is firedand trocar tip 134 rapidly pierces the patient's tissue to leave cuttingelement 132 at the target site (described in detail above with respectto FIGS. 1 and 4). The process then continues with step 2070.

At step 2070, the biopsy process is performed. Biopsy cores are severedand pulled through the system to collection canister 922 by theaspiration vacuum. Users typically rotate aperture 250 in apredetermined pattern to sample at a predetermined number of anglesaround the target site. For example, a user may rotate aperture 250 frompositions at 10:00 to 12:00 to 2:00, taking a biopsy sample at eachlocation. Moreover, the user may sample continuously around the targetlocation. In a typical sampling, the user takes biopsy samples at 2:00,4:00, 6:00, 8:00, 10:00, and 12:00 positions. In doing so, the userrotates aperture 250 using rotator 106 (see FIG. 1) when indicated by analerting mechanism, such as an audible alarm or blinking light or acombination thereof. In an embodiment having an audible alarm, once theuser hears the alarm, the user then has a predetermined time (which isadjustable) to turn rotator 106 and aperture 250, before the next biopsysample is taken. For example, console 194 may be placed into biopsy modewhich triggers an automatic sampling every five seconds. When console194 beeps, the doctor may turn aperture 250 to the appropriate locationat each and every beep. The process then continues with step 2075.

At step 2075, the biopsy process is completed and the user may verifythat tissue has been resected from the patient and is trapped incollection canister 922. The process then continues with step 2080.

At step 2080, biopsy cavity may be lavaged. The lavage function allowsfor the placement of markers in a clean cavity. It also allows for theclearing out of bodily fluids from collection canister 922 beforeremoval and harvesting of the cores taken. To lavage the biopsy cavity,console 194 is set into lavage mode where aperture 250 is open, andsaline flushes the system and the target site for about 30 seconds. Theuser may selectively shorten or lengthen the lavage time until cleanfluid is seen passing through the collection canister 922. The processthen continues with step 2085.

At step 2085, the saline supply is disabled and the target site/biopsycavity is aspirated. Surgical device 100 is also aspirated which removesfluids, e.g. saline and bodily fluids, from the system. To aspirate thesystem, stopcock 890 (see FIG. 11B) or a selectively operable luer lock,is moved to close the saline supply and opens saline line 150 toatmosphere. Thus, with console 194 in lavage mode, a vacuum is pulledthrough the system and without saline; the aspiration removes any fluidsin the system. Once the collection canister 922 is clear of saline, itcan be removed without undue leaking of saline or bodily fluids toprovide for a cleaner working environment for the user through reducedspillage of fluids. Moreover, removal of remote collection canister 922allows the specimen to be taken to a radiograph machine so that imagesmay be taken in real-time or near real-time while the patient remainsprone over the stereotactic table. The process then continues with step2090.

At step 2090, the biopsy cores are harvested from collection canister922 (see FIG. 11B). The process then continues with step 2095.

At step 2095, a treatment may be applied to the biopsy cavity.Treatments may include, for example, saline wash, haemostatic agents,drugs, or other therapies may be applied or introduced to the targetsite through saline line 150 and outer cannula 160. The process thencontinues with step 2100.

At step 2100 surgical device 110 is removed from adapter 112 and thestereotactic table. For removal, latch lever 108 is pushed up by theuser to unlock surgical device 100 from adapter 112. The user thenslides surgical device 100 off of rail 476 (see FIG. 9A). Leavingintroducer locked into adapter 112. Introducer and needle guide remain.At step 2100, surgical device 100 is removed from adapter 112 and isappropriately packaged for disposal and console 194 (see FIG. 1A) ispowered off Introducer cannula 104 remains partially within the patientand is attached to vertical portion 408 by hub snap feature 412 (seeFIGS. 7 and 7A). Thus, introducer cannula 104 provides access at distalend 130 of introducer cannula 104 (see FIG. 1) to the target site forinsertion of treatments, substances, and/or markers. Seal 410substantially prevents introducer cannula 104 from leaking (e.g., asblood, saline, adjuvant treatments, etc.) material from the target site.The process then continues with step 2110.

At step 2110, if desired, a surgical site marker is deployed throughintroducer cannula 104. A marker delivery system (not shown) may be usedthat is sized to introducer's internal diameter and length. Thus, when amarker is deployed, leakage is reduced from introducer cannula 104 andthe marker will be placed precisely in the location where tissue wasresected at the target site. Examples of a suitable marker deliverysystem are disclosed in co-pending U.S. patent application Ser. No.11/305,141 by Terry D. Hardin et al., filed on Dec. 16, 2005, thecontents of which are disclosed herein in its entirety. A deploymentpushrod will snap into introducer hub 126 to exactly locate the end ofthe deployment pushrod and mark at the exact location of the aperturethat was used to sample. The surgical site marker is typically pusheddown the lumen of introducer cannula 104 to provide a locating mechanismto ascertain the position of the target site in the future. The processthen continues with step 2115.

At step 2115, the marker delivery system is removed from introducercannula 104. Alternatively, the marker system and introducer cannula 104may be removed at the same time by unlatching introducer hub 126 fromadapter 112. The process then continues with step 2020.

At step 2120, the marker location is confirmed using an imaging modality(such as, e.g., stereotactic x-ray photography or ultrasound). Theprocess then continues with step 2025.

At step 2125, introducer cannula 104 is removed from adapter 112 and isdiscarded. However, step 2125 is skipped when the user chooses to removethe marker delivery system and introducer cannula 104 in the same stepas described above in step 2115. The process then continues with step2030.

At step 2130, the needle guide is removed and discarded. Adapter 112remains attached to the stereotactic table and may be cleaned ifnecessary. The process then ends.

In some cases a user of surgical device 100 may desire to use a separatetrocar to create a pathway for surgical device 100. For example, inthose embodiments where surgical device 100 includes a blunt tip endrather than trocar tip 134, it is desirable to use trocar 575 tofacilitate the creation of the pathway. A general process flow forutilizing trocar 575 is set forth in FIG. 17.

At step 3010, the sterile trocar 575 is unpackaged from a sealed sterileshipping/storage package. The process then continues with step 3015.

At step 3015, trocar 575 is connected to trocar holder 540. Trocarholder 540 is a permanent piece that does not come into contact withbodily fluids. As such, it is reusable for multiple procedures. Aportion of trocar 575 is engaged with seats 550, 552. In one embodiment,trocar holder 540 is provided with a clip 570 that snaps into engagementwith a groove 573 formed on a sidewall of trocar 575 to fixedly attachtrocar 575 to trocar holder 540. Once trocar 575 is engaged with trocarholder 540, the process then continues with step 3020.

At step 3020, the introducer system, including introducer cannula 104and introducer hub 126 is locked into vertical portion 408 of adapter112 (see FIGS. 7A and 17). The process then continues with step 3025.

Next, at step 3025, trocar holder 540 with trocar 575 secured thereto,is mounted to adapter 112, which in turn is mounted on a movable portionof a stereotactic table. More specifically, receiving grooves 542, 544are engaged with edges 746 of adapter 112 and slid along adapter 112until a bottom portion of trocar holder 540 reaches slot 488. At slot488, trocar holder snaps into place to fixedly secure trocar holder 540to adapter 112. Further, a tip of trocar 575, which is secured to trocarholder 540, enters into and extends through introducer cannula 104 astrocar holder 540 is slid along adapter 112. Once trocar holder 540 issecured to adapter 112, the process proceeds to step 3030.

Like the process flow described in connection with FIG. 16, at step3030, a needle guide is advanced toward the patient. The process thencontinues with step 3035.

At step 3035, the trocar 575, with the introducer cannula 104 positionedtherearound, is advanced toward the patient, through the needle guide,to create a pathway. This may be accomplished by using the stereotactictable positioning controls. The process then continues with step 3040.

At step 3040, the positioning of trocar 575 and/or introducer cannula104 is verified to insure that the pathway created by trocar 575 leadsto the desired target site. In one embodiment, stereotactic locationpairs (e.g., two or more images taken from different angles) are used toconfirm the location of trocar 575 and/or introducer cannula 104. Oncethe target is confirmed, the process then continues with step 3045.

At step 3045, trocar 575 is withdrawn from introducer cannula 104. Inone embodiment, trocar holder 540 is released from slot 488 and slidbackward along edges 746 of adapter 112, until trocar holder 540 (stillcarrying trocar 575) is disengaged with adapter 112. Once disengaged,clip 570 of trocar holder 540 is activated to release trocar 575.

In another embodiment, trocar 575 is released from trocar holder 540 (byactivation of clip 570) and withdrawn from introducer cannula 104. Then,trocar holder 540 is released from slot 488 and slid backward alongedges 746 of adapter 112 until holder is disengaged with adapter 112. Inboth embodiments, introducer cannula 104 remains in registration withthe target site. Blood and other bodily fluids are prevented fromflowing through intruder hub 126 by a normally closed seal therein. Theprocess then proceeds to step 3050.

After trocar 575 is removed, at step 3050, surgical device 100 is thenmounted to adapter 112 which is already secured to a movable portion ofthe stereotactic table. Prior to mounting surgical device 100 to adapter112, steps 2010-2030, 2040 from the process flow described in connectionwith FIG. 16 are performed.

When mounting surgical device 100 to adapter 112, a cradle 114 ofsurgical device 100 is slid along edges 746 of adapter 112 until a frontface surgical device 100 engages wall portion 408 and latch tongue 470engages latch slot 472. Further, while surgical device 100 is slid alongadapter 112, outer cannula 160 is inserted into introducer cannula 104and is moved therethrough. When surgical device 100 is moved and lockedinto position on adapter 112, cutting element 132 of outer cannula 160extends outwardly from a distal end of introducer cannula 104 (see FIG.1). Once surgical device 100 is mounted to adapter 112, the processfollows steps 2070-2130 described in connection with FIG. 16.

The present invention has been particularly shown and described withreference to the foregoing embodiments, which are merely illustrative ofthe best modes for carrying out the invention. It should be understoodby those skilled in the art that various alternatives to the embodimentsof the invention described herein may be employed in practicing theinvention without departing from the spirit and scope of the inventionas defined in the following claims. It is intended that the followingclaims define the scope of the invention and that the method andapparatus within the scope of these claims and their equivalents becovered thereby. This description of the invention should be understoodto include all novel and non-obvious combinations of elements describedherein, and claims may be presented in this or a later application toany novel and non-obvious combination of these elements. Moreover, theforegoing embodiments are illustrative, and no single feature or elementis essential to all possible combinations that may be claimed in this ora later application.

With regard to the processes, methods, heuristics, etc. describedherein, it should be understood that although the steps of suchprocesses, etc. have been described as occurring according to a certainordered sequence, such processes could be practiced with the describedsteps performed in an order other than the order described herein. Itfurther should be understood that certain steps could be performedsimultaneously, that other steps could be added, or that certain stepsdescribed herein could be omitted. In other words, the descriptions ofprocesses described herein are provided for illustrating certainembodiments and should in no way be construed to limit the claimedinvention.

Accordingly, it is to be understood that the above description isintended to be illustrative and not restrictive. Many embodiments andapplications other than the examples provided would be apparent to thoseof skill in the art upon reading the above description. The scope of theinvention should be determined, not with reference to the abovedescription, but should instead be determined with reference to theappended claims, along with the full scope of equivalents to which suchclaims are entitled. It is anticipated and intended that futuredevelopments will occur in the arts discussed herein, and that thedisclosed systems and methods will be incorporated into such futureembodiments. In sum, it should be understood that the invention iscapable of modification and variation and is limited only by thefollowing claims.

All terms used in the claims are intended to be given their broadestreasonable constructions and their ordinary meanings as understood bythose skilled in the art unless an explicit indication to the contraryis made herein. In particular, use of the singular articles such as “a,”“the,” “said,” etc. should be read to recite one or more of theindicated elements unless a claim recites an explicit limitation to thecontrary.

1. A surgical system comprising: a surgical device comprising: a housingincluding a distal end; a cutting element extending from the housing atthe distal end, wherein the cutting element may be selectively rotatedand translated; and an adapter configured to selectively and detachablyreceive the surgical device and secure the surgical device thereto suchthat the surgical device is prevented from moving independently from theadapter.
 2. The system of claim 1, further comprising a cradle top,wherein the cradle top receives a portion of the surgical device andcooperates with the adapter to secure the surgical device to theadapter.
 3. The system of claim 2, wherein the adapter includes a basesection that receives a bottom portion of the cradle top and a wallportion that extends upwardly from the base section.
 4. The system ofclaim 3, wherein the cradle top further comprises a latch thatcooperates with a latch member formed on a portion of the base sectionof the adapter to selectively and detachably secure the cradle top tothe adapter.
 5. The system of claim 1, wherein the adapter furtherincludes at least one mounting hole formed therein for securing theadapter to a selectively movable stage.
 6. The system of claim 1,further comprising an introducer assembly that comprises an introducerhub and an introducer cannula.
 7. The system of claim 6, wherein theintroducer assembly is removably secured to a portion of the adaptersuch that the introducer assembly is prevented from moving independentlyfrom the adapter.
 8. The system of claim 7, wherein the introducerassembly is secured to a wall portion of the adapter that extendsupwardly from a base portion of the adapter.
 9. The system of claim 6,wherein the introducer hub includes a normally closed seal that may beselectively opened by the introduction of a portion of cutting elementof the surgical device.
 10. The system of claim 1, further comprising aconsole that supplies power and vacuum to the surgical device.
 11. Thesystem of claim 10, further comprising a tissue collection canisteroperably connected to the surgical device for receiving tissue samplesexcised by the surgical device.
 12. The system of claim 11, wherein thetissue collection canister is positioned remotely from the surgicaldevice and operably connected thereto by an aspiration line.
 13. Thesystem of claim 12, wherein one end of the aspiration line is connectedto portion of the surgical device.
 14. The system of claim 1, furthercomprising a rotator operatively connected to the surgical device,wherein the rotator is selectively rotatable to position the cuttingelement.
 15. The system of claim 14, further comprising a rotationindicator that indicates the position of the cutting element.
 16. Thesystem of claim 15, wherein the rotation indicator is a window that isformed in a portion of the housing of the surgical device so to exposean inner portion having indicia that rotates along with the rotator. 17.The system of claim 1, further comprising a remote valve operablyconnected to the surgical device, wherein the remote valve isselectively actuatable to operate the cutting element of the surgicaldevice.
 18. The device of claim 1, further comprising a fluid line fordelivering fluid to said cutting element.
 19. The device of claim 1further comprising a trocar holder and a trocar, wherein the trocarholder may be selectively and detachably engageable with the adapter toposition the trocar.
 20. The device of claim 1, wherein the trocar maybe selectively disengaged with the trocar holder.